What are the responsibilities and job description for the Process Engineer position at Flambeau Medical?
Job Description
Job Description
Position : Process Engineer
About Cinova Medical :
Cinova Medical is a full-service, contract manufacturing organization serving the medical device and life Sciences industries. Each member of our executive leadership team has over 25 years serving in the industry. We provide a full suite of development and manufacturing capabilities in our FDA registered and ISO-13485 : 2016 certified manufacturing operations located in Phoenix, Arizona. Cinova Medical produces medium-to-high volume molded components, secondary operations, fully automated assemblies, Class ll finished device manufacturing, and sterile barrier packaging in our Class 7 & Class 8 clean rooms. We proudly serve many of the world’s leading medical device manufacturing companies.
If you’re good at what you do, you can work anywhere. If you’re the best at what you do, come work at our company.” We are committed to growing the capabilities of our people.
Summary :
Responsible for developing manufacturing processes for plastic injection molded components. The engineer will develop processes by establishing injection molded cycles of new and existing molds. The engineer will also define pre and post molded processes to optimize efficiencies, yields and productivity. The engineer will use process capability studies and other statistical techniques for defining process capability, identifying and eliminating sources of process variability. This individual will provide engineering support to production by troubleshooting injection molding processes and tooling, and by defining mold maintenance requirements. This individual will be responsible for providing customer support for new product development and resolving any quality problems with components.
Responsible for creating and promoting all internal and external ECO’s and ECN’s by using ERP system
Essential Duties and Responsibilities :
- Develop programs and / or methods to optimize productivity and reduce cycle time, manufacturing losses, and overall costs
- Develop and execute project plans. Develop documentation for each project and work with associated plant personnel to implement it
- Establish process development technical guidelines
- Maintain all BOM’s updated on a daily, weekly, monthly basis
- Quote existing part numbers after making sure the BOM’s have been updated to reflect the correct sell price
- Ensure that manufacturing requirements are properly developed and documented in conjunction with appropriate manufacturing, production, and engineering personnel
- Assure that the process of product adheres to ISO 13485 standards
- Continuously improve existing processes using design of experiments and other methods to increase efficiencies
- Support the product development process by assisting the program teams as necessary to ensure successful product launches
- Provide information and technical assistance to manufacturing, engineering, and production personnel as required
- Implement Process Control and Process Discipline systems into manufacturing operations
- Mold validation process set-up, troubleshooting and process monitoring
- Quotes, procures, modifies and validates both new and existing production mold tooling
- Resolves technical tooling and process problems associated with both new and old tooling
- Assists in selection of tooling vendors
- Directs vendor interface, coordinates in-process changes and approves tooling upon completion
- Works with our vendors to perform new or modified component validations as applicable; determines the requirements and directs any tooling upgrades to existing tooling
- Monitors all molding operations, tracking efficiency and potential issues
- Scientific approach to problem solving machine issues. Tracks statistical data and utilizes SPC to continuously monitor and improve the efficiency of the molding operations
- Participates in variation scrap and cost reduction opportunities
- Works as a cross-functional team member with involvement in processes, various designs, troubleshooting, project management and cost analysis
- Assists in the collection of information, selection and implementation of new molding projects
- Creates procedures, routings and BOM’s. Assists with corrective actions to resolve non-conformances as root causes are identified
- Optimize manufacturing practices
- Improve workforce by training Process Technicians and Mold Technicians on machine efficiency
- Processing techniques as well as other data-based methods of decision making
- Other projects and tasks as assigned
Qualifications :
Education / Experience :
BS Degree in engineering or 5 years of experience as a Master Molder preferred
Language Ability :
Ability to read, write, understand and follow instructions in the English language.
Effective oral and written communication in the English language.
Certificates and Licenses :
Master Molder
Supervisory Responsibilities :
None
Work Environment :
Physical Demands :
Visual Acuity :
Job Type : Full-time
Benefits : Medical; Dental; Vision; Life; STD; LTD; 401(k) with company match; Paid Time Off
Out of state candidates are encouraged to apply. Cinova Medical will provide RELOCATION BONUS.
Work in a place where your team values you.” Experience what being a part of the Cinova Medical family feels like. Be inspired by your leaders and be encouraged and cheered on by your teammates.
Cinova Medical, Inc. is an EOE AA M / F / Vet / Disability Employer and Drug Free Workplace.
Upon hire, Cinova Medical, Inc. uses E-Verify to verify employment eligibility for roles based in the United States.
